ADONIS 20 mg Tablets/Film-coated

What is ADONIS 20 mg

ADONIS 20 mg is a film-coated tablet containing 20 mg of tadalafil, a phosphodiesterase-type-5 (PDE-5) inhibitor indicated primarily for the symptomatic treatment of erectile dysfunction (ED) in adult males. Tadalafil is also approved, at lower daily doses, for benign prostatic hyperplasia (BPH) and pulmonary arterial hypertension (PAH); however, ADONIS 20 mg is formulated for the on-demand management of ED, offering a therapeutic window of up to 36 hours—considerably longer than first-generation PDE-5 inhibitors.

• Active ingredient: Tadalafil 20 mg per tablet (film-coated).
• Pharmacological class: Selective, reversible PDE-5 inhibitor.
• Key benefit: Facilitates penile erection in response to sexual stimulation by enhancing nitric-oxide–cGMP signalling in the corpus cavernosum.
• Onset & duration: Median onset ≈ 30 minutes (range 15–45 min); therapeutic effect may persist for up to 36 hours, earning the nickname “the weekend pill.”
• Regulatory status: Prescription-only medicine (Rx); not indicated for use in women or persons < 18 years.
• Distinguishing features: Longer half-life (~17.5 h) compared with sildenafil or vardenafil, allowing greater spontaneity.
• Packaging: Blister pack of four tablets, each embossed for dose verification and coated to mask taste.
• Manufacturer information: See outer carton or patient-information leaflet (PIL) for MA holder, batch number, and expiry.
• Therapeutic context: Should be part of a broader ED work-up that screens for cardiovascular disease, endocrine disorders, or psychosocial factors.
• Patient counselling tip: ADONIS 20 mg does not increase libido; sexual arousal is still required to achieve an erection.

How to use ADONIS 20 mg

Correct use maximises efficacy while minimising adverse events. The guidance below reflects current consensus (European Association of Urology, 2023) and manufacturer recommendations.

• Timing: Swallow one tablet with water at least 30 minutes before anticipated sexual activity; a light meal has no clinically relevant effect, but a high-fat meal may delay onset.
• Frequency: Do not exceed one 20 mg tablet within a 24-hour period; the prolonged half-life means repeat dosing confers minimal added benefit and raises risk of adverse effects.
• Administration route: Oral; do not crush or split the film-coated tablet.
• Hydration: Take with a full glass of water to aid oesophageal transit and reduce dyspepsia.
• Alcohol: Limit to ≤ 5 units; excessive alcohol amplifies hypotensive effects and impairs erectile function independently.
• Missed opportunity: If sexual activity is postponed, no “make-up” dose is needed; wait ≥ 24 h before the next tablet.
• Special populations:
  • Elderly (≥ 65 y): No routine dose adjustment, but start at 10 mg in frail adults.
  • Renal impairment: Moderate (CrCl 30–50 mL/min)— maximum 10 mg once every 48 h; severe (CrCl < 30 mL/min)— avoid.
  • Hepatic impairment: Mild-to-moderate (Child-Pugh A/B)— consider 10 mg; severe (Child-Pugh C)—contraindicated.
• Patient follow-up: Reassess efficacy, tolerability, and cardiovascular status after 4–6 doses; consider alternative doses or daily 5 mg regimen if spontaneity is a priority.
• Partner involvement: Encourage open discussion with the partner to align expectations and alleviate performance anxiety.

Mode of Action ADONIS 20 mg

Tadalafil exerts its pro-erectile effect by selectively inhibiting phosphodiesterase-type-5 (PDE-5), the enzyme responsible for degradation of cyclic guanosine monophosphate (cGMP) in the smooth muscle of the corpus cavernosum.

• Physiological cascade: Sexual stimulation releases nitric oxide (NO) from non-adrenergic, non-cholinergic neurons and endothelium ➜ NO activates guanylate cyclase ➜ ↑ cGMP ➜ smooth-muscle relaxation ➜ vasodilatation ➜ increased arterial inflow and restricted venous outflow ➜ erection.
• Enzymatic blockade: PDE-5 hydrolyses cGMP to inactive 5′-GMP. By inhibiting PDE-5, tadalafil sustains cGMP levels, amplifying and prolonging the vasodilatory response.
• Selectivity: High affinity for PDE-5 with a ≥ 10-fold selectivity over PDE-6 (retina) and ≥ 700-fold over PDE-3 (cardiac/vascular), reducing visual and cardiac side effects compared with less selective agents.
• Pharmacokinetics: Oral bioavailability ≈ 80%; peak plasma concentration (T_max) in 2 h; protein binding 94%; half-life ~17.5 h, accounting for the 36-h therapeutic window.
• Metabolism & elimination: Hepatic CYP3A4-mediated oxidation to inactive catechol metabolites ➜ renal and faecal excretion.
• Haemodynamic profile: Minimal effect on systemic blood pressure in normotensive men; potentiation occurs with nitrates and α-blockers, underscoring interaction risks.
• Extra-cavernosal effects: PDE-5 is expressed in prostate, bladder, and pulmonary vasculature, explaining efficacy in BPH symptom relief and PAH at alternative dosing.

ADONIS 20 mg Interactions ADONIS 20 mg

Tadalafil’s safety profile depends heavily on recognising pharmacodynamic and pharmacokinetic interactions. Co-administration with the following agents or substances warrants caution or outright avoidance:

• Nitrates (e.g., nitroglycerin, isosorbide dinitrate): Absolute contraindication. Synergistic NO-cGMP elevation can cause profound, refractory hypotension.
• Guanylate cyclase stimulators (riociguat): Additive hypotension—avoid.
• α-Adrenergic blockers (doxazosin, tamsulosin): Start at the lowest α-blocker dose and separate administrations by ≥ 6 h; monitor blood pressure.
• Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat, clarithromycin): ↓ tadalafil clearance ➜ ↑ AUC; limit tadalafil to 10 mg every 72 h or avoid.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St John’s Wort): ↑ tadalafil metabolism ➜ therapeutic failure; consider dose adjustment or alternative therapy.
• Antihypertensives (ACEIs, ARBs, β-blockers, diuretics): Modest additional BP reduction; monitor for dizziness or syncope.
• Ethanol: High intake potentiates orthostatic hypotension and dizziness; counsel moderation.
• Grapefruit juice: Moderate CYP3A4 inhibition may elevate tadalafil levels; occasional consumption is unlikely to be clinically significant but advise spacing by ≥ 24 h.
• Other PDE-5 inhibitors (sildenafil, vardenafil) or recreational “poppers” (amyl nitrite): Concomitant use is unsafe and offers no added benefit.

Dosage of ADONIS 20 mg

The 20 mg strength is formulated for on-demand use in erectile dysfunction, not for daily chronic administration. Evidence-based dosing strategy:

• Standard adult dose: One 20 mg tablet taken orally prior to anticipated sexual activity; effective from 30 min up to 36 h.
• Initiation: In treatment-naïve patients, consider starting at 10 mg to assess tolerability; escalate to 20 mg if response is inadequate.
• Maximum frequency: Once daily; repeated dosing within 24 h confers little benefit due to long half-life.
• Renal adjustment:
  • Creatinine clearance 30–50 mL/min: 10 mg as needed, max every 48 h.
  • < 30 mL/min or on dialysis: Use not recommended.
• Hepatic adjustment:
  • Mild-to-moderate impairment (Child-Pugh A/B): Begin with 10 mg.
  • Severe impairment (Child-Pugh C): Contraindicated.
• Elderly (≥ 65 y): Pharmacokinetics largely unchanged; clinical judgement dictates starting at 10 mg if comorbidities present.
• Duration of trial: Evaluate efficacy after at least four attempts; psychological factors may require more exposures for reliable assessment.
• Switching regimens: Patients needing greater spontaneity can transition to 5 mg once daily, taken at the same time each day regardless of sexual activity.
• Therapy review: Re-evaluate cardiovascular risk, medication interactions, and ED aetiology at 3- to 6-month intervals.

Possible side effects of ADONIS 20 mg

Tadalafil is generally well-tolerated; most adverse events are mild-to-moderate and transient. Vigilance remains essential, especially in polypharmacy and cardiovascular disease.

• Very common (≥ 10 %):
  • Headache
  • Flushing
• Common (1–10 %):
  • Dyspepsia, gastro-oesophageal reflux
  • Nasal congestion, rhinitis
  • Back pain, myalgia (often delayed 12–24 h post-dose)
  • Dizziness
  • Visual colour tinge or mild blurred vision
• Uncommon (0.1–1 %):
  • Palpitations, tachycardia
  • Hypotension or hypertension
  • Epistaxis
  • Ocular hyperaemia
  • Rash, pruritus
• Rare (< 0.1 %):
  • Priapism (erection > 4 h)—urological emergency
  • Non-arteritic anterior ischaemic optic neuropathy (NAION)
  • Sudden hearing loss, tinnitus
  • Severe cutaneous reactions (Stevens-Johnson syndrome)
  • Angina, myocardial infarction in predisposed patients
• Post-marketing signals: Hypersensitivity, stroke, ventricular arrhythmia—causality often confounded by underlying cardiovascular risk.
• Management: Advise patients to seek immediate medical attention for chest pain, vision/hearing changes, or erections > 4 h.

ADONIS 20 mg Contraindications ADONIS 20 mg

Tadalafil must not be used where the risk of adverse cardiovascular or drug-induced events outweighs the benefit.

• Concomitant nitrate therapy: Any form of organic nitrate or nitric-oxide donor.
• Severe cardiovascular disorders:
  • Recent myocardial infarction or stroke (< 90 days)
  • Unstable angina, uncontrolled arrhythmias
  • Severe hypotension (BP < 90/50 mmHg) or uncontrolled hypertension (BP > 170/100 mmHg)
  • NYHA class III–IV heart failure not stabilised on therapy
• Severe hepatic impairment (Child-Pugh C)
• Severe renal impairment (CrCl < 30 mL/min) or dialysis dependence
• Hereditary degenerative retinal disorders (e.g., retinitis pigmentosa)
• Known hypersensitivity to tadalafil or excipients
• Concomitant guanylate cyclase stimulators (e.g., riociguat)
• Pediatrics: Safety and efficacy not established in individuals < 18 years

Storage of ADONIS 20 mg

Proper storage preserves drug potency and patient safety.

• Temperature: Store below 30 °C (86 °F); avoid refrigeration or freezing.
• Humidity: Keep in the original aluminium-PVC blister until use to protect from moisture; do not decant into pill organisers unless moisture-proof.
• Light protection: Film-coated tablets are stable under normal lighting, but prolonged exposure to direct sunlight should be avoided.
• Child safety: Store out of sight and reach of children; consider a locked cabinet for households with minors.
• Transportation: During travel, use an insulated pouch if ambient temperatures exceed 30 °C (e.g., summer car glove box).
• Expiry: Check the embossed date on the carton and each blister; discard unused tablets after expiry or if integrity is compromised (e.g., tablets chipped or discoloured).
• Disposal: Return expired or unused medication to a pharmacy take-back program; avoid flushing or discarding in household trash to reduce environmental impact.
• Patient reminder: Retain the package insert for reference on interactions, side effects, and emergency guidance.